Journal of Pain Research (Sep 2021)
High-Frequency Impulse Therapy for Treatment of Chronic Back Pain: A Multicenter Randomized Controlled Pilot Study
Abstract
Kasra Amirdelfan,1 Mindy Hong,2 Bobby Tay,3 Surekha Reddy,4 Vinay Reddy,4 Michael Yang,5 Krishn Khanna,3 Prasad Shirvalkar,6 Christopher Abrecht,7 Amitabh Gulati8 1IPM Medical Group, Walnut Creek, CA, USA; 2Hinge Health, San Francisco, CA, USA; 3Department of Orthopaedic Surgery, University of California San Francisco, San Francisco, CA, USA; 4Spine and Nerve Diagnostic Center, Roseville, CA, USA; 5Summit Pain Alliance, Santa Rosa, CA, USA; 6UCSF Weill Institute of Neurosciences University of California San Francisco, San Francisco, CA, USA; 7Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA, USA; 8Memorial Sloan Kettering Cancer Center, New York, NY, USACorrespondence: Amitabh GulatiMemorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USATel +1 212 639-2000Email [email protected]: This study aims to examine high-frequency impulse therapy (HFIT) impact on pain and function among patients undergoing care for chronic low back pain (CLBP).Methods: A pilot randomized-controlled trial of HFIT system versus sham was conducted across 5 orthopedic and pain center sites in California, USA. Thirty-six patients seeking clinical care for CLBP were randomized. Primary outcome was function measured by the Six Minute Walk Test (6MWT). Secondary outcomes were function (Timed Up and Go [TUG] and Oswestry Disability Index [ODI]), pain (Numerical Rating Scale [NRS]), quality of life (Patient Global Impression of Change [PGIC]), and device use. Patients were assessed at baseline and every week for 4 weeks of follow-up. Mann–Whitney U-test was used to analyze changes in each outcome. Repeated measures ANOVA was used to assess the effect of treatment over time.Results: The average age of subjects was 53.9 ± 15.7 (mean ± SD) years, with 12.1 ± 8.8 years of chronic low back pain. Patients who received an HFIT device had a significantly higher 6MWT score at weeks 2 [Cohen’s d (95% CI): 0.33 (0.02, 0.61)], 3 [0.32 (0.01, 0.59)] and 4 [0.31 (0.01, 0.60)], respectively, as compared to their baseline scores (p < 0.05). Patients in the treatment group had significantly lower TUG scores at week 3 [0.30 (0.04, 0.57)] and significantly lower NRS scores at weeks 2 [0.34 (0.02, 0.58)] and 4 [0.41 (0.10, 0.67)] (p < 0.05).Conclusion: A larger-scale RCT can build on the findings of this study to test whether HFIT is effective in reducing pain and improving function in CLBP patients. This study shows encouraging evidence of functional improvement and reduction in pain in subjects who used HFIT. The efficacy and minimally invasive nature of HFIT is anticipated to substantially improve the management of CLBP patients.Keywords: HFIT, pain, chronic pain, neuromodulation, noninvasive treatment
